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Amniotic fluid plays a significant role in fetal gut maturation and development. The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among neonates recovering from surgery for congenital bowel abnormalities, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering from GIT surgeries.
Neonates with congenital GIT anomalies will participate after being operated.
Participants will be followed for the duration of hospital stay until discharge or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAFE group | Experimental | SAFE group: simulated amniotic fluid 20cc/kg/day enterally divided according to number of feds (syringe for every fed). This amount provides enteral 4.5μg rhG-CSF / kg/day and enteral 88IU rhEPO / kg/day. |
|
| Placebo | Placebo Comparator | Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAFE group | Drug | simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Signs of feeding intolerance | Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing enterocolitis | • Clinical signs of suspected NEC (abdominal distension, increased volume of gastric aspirate, bile stained aspirate, and / or apnea or bradycardia), and Bell's modified criteria for staging (Bell et al., 1978). | The outcome measure will be assessed within 2 months |
| hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania A El-Farrash, MD | Contact | 00201222208550 | raniafarrash@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rania A El-Farrash, MD | ASU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | 1138 | Egypt |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| placebo group | Drug | distilled water 20 ml/kg/day for maximum of 7 days. |
|
|
duration on hospitalization |
| through study completion, an average of 1 year |
| mortality | death | he outcome measure will be assessed within 2 months |
| D007410 |
| Intestinal Diseases |